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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034616
Receipt No. R000039470
Scientific Title Sarcopenia in hemodialysis patients and blood ghrelin and leptin concentration
Date of disclosure of the study information 2018/10/24
Last modified on 2019/04/24

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Basic information
Public title Sarcopenia in hemodialysis patients and blood ghrelin and leptin concentration
Acronym Sarcopenia in hemodialysis patients and blood ghrelin and leptin concentration
Scientific Title Sarcopenia in hemodialysis patients and blood ghrelin and leptin concentration
Scientific Title:Acronym Sarcopenia in hemodialysis patients and blood ghrelin and leptin concentration
Region
Japan

Condition
Condition Chronic renal failure
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether blood ghrelin and leptin concentrations are involved in the development of sarcopenia in hemodialysis patients
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference in blood ghrelin and leptin levels between hemodialysis patients complicated with or without sarcopenia
Key secondary outcomes Difference in dietary intake and appetite between hemodialysis patients complicated with or without sarcopenia

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Hemodialysis patients in our hospital outpatient clinic

Key exclusion criteria Patients complicated with serious diseases such as cancer, hematological disorders, and liver cirrhosis
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Michio
Middle name
Last name Kuwahara
Organization Saitama Tsukinomori Clinic
Division name Nephrology
Zip code 339-0012
Address 366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
TEL 048-792-1811
Email kuwahara@k-naika-cl.jp

Public contact
Name of contact person
1st name Megumi
Middle name
Last name Kobayashi
Organization Saitama Tsukinomori Clinic
Division name Nutrition
Zip code 339-0012
Address 366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
TEL 048-792-1811
Homepage URL
Email kobayashim@k-naika-cl.jp

Sponsor
Institute Saitama Tsukinomori Clinic
Institute
Department

Funding Source
Organization Saitama Tsukinomori Clinic
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization the ethics committee of Saitama Tsukinomori Clinic
Address 366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
Tel 0487921811
Email kuwahara@k-naika-cl.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 23 Day
Date of IRB
2018 Year 10 Month 23 Day
Anticipated trial start date
2018 Year 10 Month 24 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a prospective observational study for hemodialysis patients. We are targeting patients currently visiting our hospital and we do not recruit general people.

Management information
Registered date
2018 Year 10 Month 24 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039470

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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